27 Responses

  1. Laura
    Laura January 17, 2011 at 6:30 am | | Reply

    What is the role of the governmental regulatory bodies in all these delays? What does the future hold for these governmental bodies approving devices? If they are delaying which is part of the problem or most of the problem…what can we do about it?
    As far as newcomers…well I would not trust to any of them without a proven track record. You might find the company going out of business or with little customer support.

  2. Bernard Farrell
    Bernard Farrell January 17, 2011 at 6:44 am | | Reply

    Amy (and David), thanks for a most useful summary. It seems as if the FDA is holding up a good deal of development work. Is there any way we can exert influence on them to speed up the process? Should we be talking with our legislators about this?

  3. Leighann of D-Mom Blog
    Leighann of D-Mom Blog January 17, 2011 at 7:41 am | | Reply

    It’s sad to see that two things I’ve been looking forward to, smaller OmniPod and iBGstar, are pushed back.

    Would I pay a percentage of the upgrade to the OmniPod PDM with CGM integration? I probably would depending on the cost and how “integrated” the system actually is. OmniPod currently offers people with other pumps to switch for $149 (I think, or something like that). That price tag would be reasonable to me.

    The next question would be insurance coverage. I know a lot of insurance companies won’t approve CGM’s for younger patients. Our particular insurance won’t typically approve them for patients under 25!!

    If OmniPod could work with current users to help get insurance approval fast tracked, then I think a lot more people would be willing or interested in switching to the new OmniPod/CGM system.

    What we love about OmniPod right now is that our young child does not have to have the PDM on her body at all times (as opposed to insulin pumps w tubes which require children to wear a fanny pack or have it clipped to their clothing). I’m assuming that CGM integration means that my daughter would have to have the PDM on her at all times.

    At home we keep her PDM in her “pump bag” (a small purse) hanging on the door knob in the kitchen. At school she keeps it on the shelf right inside her classroom door. Everyone knows where it is and they get it as needed.

    By the time CGM integration is a reality and we got through the insurance approval process, my child would no longer be a tiny six-year-old, so carrying the PDM may not be as much of an issue.

    (Long comment from me AS ALWAYS!)

  4. Lorraine
    Lorraine January 17, 2011 at 8:16 am | | Reply

    Fantastic review! Thanks so much for the info Amy and David.

    And yes – willing to pay for the updated PDM. I don’t see why Insulet should have to bear that cost.

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  6. David
    David January 17, 2011 at 10:18 am | | Reply

    Love the update. I also wonder what’s going with the FDA. From the outside It sure looks as if they are unnecessarily restrictive and should make large scale changes in policy.

  7. Penny
    Penny January 17, 2011 at 11:48 am | | Reply

    Thanks for the update about the smaller pod. We are excited here and cannot wait for a smaller, more slimlined pump. I think it will attract even more people to the OmniPod and make it even more discrete. And yes, I would certainly pay, out of pocket even, to upgrade to the new PDM when it is integrated with Dexcom. And like Leighanne said, many of us are fighting insurance companies about a CGM for the younger folk – G’s Medicaid will not pay for a CGM – AT ALL. So, integrating them both into her actual pump she is using might prove a bonus for us – it’s already in there. Interesting stuff to pose to the insurance company and personally I cannot wait for the day!

  8. Frank G
    Frank G January 17, 2011 at 11:55 am | | Reply

    Nothing from Abbott? As a happy Freestyle Navigator user this worries me.

    Also – ironic that news on diabetes devices has to come from conference from **investors**. Shows you where the pharma corps focus!

  9. kim
    kim January 17, 2011 at 7:01 pm | | Reply

    I wonder if Insulet has considered new users? As a Medtronic pump customer, I have been holding out for their patch pump. I’ll take which ever integrated tubeless system arrives first, and pay for the upgrade.

  10. Karen
    Karen January 18, 2011 at 6:22 am | | Reply

    Thanks for the great update. Since my pump warranty expires in a little over a year, I love to read about the new improved options that may be available to me. I’m also really excited about the BGStar meter – hopefully we will see it’s release in 2011. That Pogo system was new to me, although it looks very very similar to my Accu-Check Compact Plus. I was disappointed that I couldn’t find any information on the Pogo web-site about the size of the system. I love my Compact Plus but I’ve always wished it was smaller.

  11. Cary
    Cary January 18, 2011 at 2:45 pm | | Reply

    Not many surprises here. The issues getting FDA approval on new pod design have been known for a while (would not surprise me if they start shipping limited quantities before 2012). The true backstory on Dexcom/Insulet are probably a whole lot more messy than meets the eye. Hopefully they can figure it out and do not have a falling out.

    Insulet needs some competition in the patch-pump market. Once someone else does it – it is really going to make competition a reality (either Insulet prevails and improves their product ahead of all the others awaiting approval or someone else will).

    I’m still amazed that BGStar is going with a plug-in approach to the iPhone. The bluetooth is there – use it! It would also open up their device to other avenues — android, blackberry, and of course actual computers…

    One of these days we’ll get current-decade technology to the user.

  12. Leighann of D-Mom Blog
    Leighann of D-Mom Blog January 19, 2011 at 7:07 am | | Reply

    Any word on whether OmniPod and CGM integration means a choice of two different pods and PDM’s or if ALL the pods shipping after integration will have the CGM in them?

    I assume there will be an increase in price to include the CGM and I hope that is not a cost that non-CGM users will have to bear.

    That being said, if it is included and the same price, it may be easier to get insurance companies to approve. I don’t know.

    I almost hope that there is separate pricing based on whether or not you want the CGM because I would NOT be happy to pay a higher price for pods if we aren’t actually using the CGM technology.

    (And like I’ve said before, I don’t think we are even considering CGM until there is integration.)

  13. Eva Clarke
    Eva Clarke January 19, 2011 at 8:23 pm | | Reply

    This was a great update, yet again the FDA delays in approving the new products is disappointing.

    It is interesting that the technology companies are talking to investors, but not the end users. I use the omnipod and am disappointed that the PDM looks like a 1980′s garage door opener. Why can’t it look like a smart phone or ipod? I can’t fit it into my jeans pockets like I can my phone. Why is there just ONE style of PDA?

    Why does the insulet pump only offered in white? It could come in several skin color shades, so its not so noticeable.

    I believe the integration of the omnipod and the dexcom CGM would occur by having a single PDA controlling both devices. You would still have to wear two devices -the pump and the CGM.

    Let us know how we can persuade the FDA and the companies to move more quickly on these products.

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  16. Mike Feiman
    Mike Feiman January 25, 2011 at 7:25 am | | Reply

    It’d be nice if Insulet could get more insurance companies to pick up coverage. My daughter is using the Omnipod (and is really looking forward to the smaller version), but it’s pretty spendy without Kaiser footing part of the bill.

  17. Joltdude
    Joltdude January 25, 2011 at 7:48 pm | | Reply

    FDA is kind of against using Bluetooth, hence why theres been sort of a hold on meters with BT technology, like the Agamatrix Wavesense Jazz Wireless, and thats why they went the route they did with the BGStar…

    The FDA doesn’t want to certify IOS or other OS’s (Android)… ideally they want all meters to be propriatary and can only send data to another device.. cant interact with it…

    This is also why theres not much Windows 7 updates to pump/cgm/meter software…. i honestly think they are being too protective since most stuff is already at the users risk..

  18. Scott K. Johnson
    Scott K. Johnson February 15, 2011 at 7:47 pm | | Reply

    Interesting stuff. Thank you Amy and David.

    Wouldn’t it be great to see something really revolutionary in the world of diabetes? Unfortunately, the FDA wants to see something that’s already been proven safe, which usually means a copy of an existing thing, or an expensive study proving the new thing is safe.

    What new company would want to fund such a study? It’s too expensive.

  19. Anne Findlay
    Anne Findlay June 1, 2011 at 4:02 pm | | Reply

    do you have any info on whether omnipod has plans to reduce the size of the PDM? I’d love a mini-controller that just had bolus/basal adjustment functions w/o the rest of the bulk/weight.

  20. Jean Haight
    Jean Haight September 11, 2011 at 11:38 am | | Reply

    I’m very interested in this new smaller Pod. Ihave been wearing the original Omni Pod for over 5 years. I have been campaigning to have the Omni Pod coverd by Medicare. Will there be an issue with Medicare coverage for this new Pod?

    I think the Omni Pod is the best thing to hit the market for diabetics since Insulin.

    I have my fingers crossed.

  21. Jean Haight
    Jean Haight September 11, 2011 at 11:55 am | | Reply

    I have been a diabetic since I was 18 mos old,back then glass syringes with a bblue glass plunger and a metal needle had to be boiled before every use. It was a problem when we went to visit my aunt in New Jersy,because there was something to do with the water ther and whenever my parenst did the boiling that was recquired the syringe jammed and I had to go to the hospital to have an insulin injection. We went back to my Aunts house and my father,mother ,and 2 sisters and 1brother were piled in the car and on the way back to Boston. Next came the plastic syringed they were oook.
    What seemed like a great number of years later came the plastic syringes by BD,they’re still on the market. Then started the pumps with all kinds of tubing which would easily catch on to belt buckles when you were in the ladies room.

    I’ve been through almost every step of advancing the Omni Pod made by the Insulet Corporation,so now the Congress put Code Numbers on it and made it disposable. I’ve petitoned the Congress with others to change the Code Numbers to a durable Code.
    I hope they will put a code number on the newer pump allowing it to be covered by Medicare.

    If you’re not approaching 65 you’re pretty safe,and will have plenty of time to “Fight Washington.”

  22. Jean Haight
    Jean Haight September 30, 2011 at 8:34 am | | Reply

    I hope that someother diabetics that use the Omni Pod Insulin Pump will contact here Representative in Congress to have the Code Numbers on the Omni Pod changed from POD A 9274 and PDME 0784 to a durableCode Number.

    So far I have support from Congressperson David Cicilline and David Gregory from MSNBC.
    Contact anyone and everyone that is on MSNBC and The Representative that are representing your area in Congress. Get in touch with Jill Biden she is an MD.

    Contact the President and the Vice President tohelp get the code numbers changed.

    We shouldn’t be punished because we have diabetes.

  23. Jean Haight
    Jean Haight September 30, 2011 at 8:40 am | | Reply

    I’ve contacted David Gregory who has given me a thumbs up. I’ve tried to contac Joe Scarborough with no success.

    Contact your Representatives,they are the ones who applied the “disposable item” code numbers to the Omni Pod.

    Lets stick together and get those Code numbers changed. Remember a lot of these Representatives want to return after the nex election!

  24. Jean Haight
    Jean Haight September 30, 2011 at 8:49 am | | Reply

    Keep on contacting the Congresspersons who represent you. Remind them that we hire and fire them.

    We want a durable code number applied to the Omni Pod Insulin Pump. It’s up to theRepresentatives in Congress to do this.

    If their not interested in returning after the next election they can ignore us.

    This pump is the best thing that has been on the market in all the years that I’ve been a diabetic.

    Iwas diagnosed when I was 18 mos old in Feb.1950. I am now 62 years old and I’m not going to give up the battle.

  25. Lance
    Lance October 24, 2011 at 3:45 pm | | Reply

    I’m so tired of carrying my Dexcom 7plus and my smart phone. When will somebody do the obvious and integrate a BG sensor with the smartphone. The software app is a weekend’s work for a decent programmer and how hard is it to design a transmitter/antenna that would fit into a SD card slot? Please this is not rocket science somebody make this happen. Screw the FDA cert, just sell it as plug in hardware and an android app, no need to get big brother involved.

  26. Kevin
    Kevin August 29, 2012 at 6:32 am | | Reply

    Any updates on when/if the updated versions will be made available?

  27. NewsFlash: Dexcom’s Next-Gen “Platinum” CGM Approved by FDA! | SweetInfo

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